BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that an uphold¿ lite device was used during a sacrospinous ligament (ssl) fixation procedure performed on (b)(6) 2017.According to the complainant, during the procedure,the needle detached after it was caught in the capio cage.The procedure was completed with another uphold¿ lite device.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Analysis of the returned device revealed that the suture on the blue with white stripe dilator is broken off at the distal end of the dilator and was not returned.The mesh was cut into two pieces most likely to facilitate removal of the device.Analysis also revealed that there was no damage to the capio slim suture capturing device.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.The investigation concluded that this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.
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Event Description
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It was reported to boston scientific corporation that an uphold lite device was used during a sacrospinous ligament (ssl) fixation procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the needle detached after it was caught in the capio cage.The procedure was completed with another uphold lite device.The patient's condition at the conclusion of the procedure was reported to be stable.
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